Medical Director - Oncology , Home- Based at IQVIA

İstanbul, İstanbul, Türkiye

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Medical expertise to provide oversight for clinical trials as Medical Monitor, including 24/7 availability for protocol queries, site support, and safety issues
Ability to function as a team member in a matrix reporting structure within project teams
Knowledge of GCP (Good Clinical Practice) to ensure medical activities operate efficiently and compliantly
Experience in oncology or related therapeutic areas for protocol training and support
Network of medical/scientific consultants and key opinion leaders
Supervisory skills to manage Medical Director activities

Responsibilities

Provide medical and scientific input to clinical research programs, including review of new business proposals, preclinical/clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plans, clinical study reports, regulatory submissions, and adverse event evaluations
Interact with clients on drug development programs, study design, and protocol development, including input on inclusion/exclusion criteria, study endpoints, statistical/data management sections, and final protocol review for clinical, safety, and efficacy variables
Provide project team training on protocols and therapeutic areas
Assist with investigator site selection, networking, recruitment, and retention activities, including calls to key opinion leaders and presentations at investigator meetings
Develop project medical monitoring plans and provide on-call coverage for protocol queries and site support as first-line contact for medical/safety issues
Verify medical accuracy of patient safety data, conduct ongoing safety profile assessments, review SAE reporting, write/review SAE narratives, track SAEs, interact with sponsors/sites on safety issues, review IND/SUSAR reports, update Investigator Brochures, and annual IND reports
Consult with sponsors on breaking the blind for subject treatment assignments and interact with FDA officials on safety/study issues as requested
Establish and maintain networks of medical/scientific consultants and supervise Medical Director activities

Skills

Key technologies and capabilities for this role

Medical MonitoringClinical TrialsGCPProtocol ReviewAdverse Event EvaluationDrug DevelopmentInformed ConsenteCRFsClinical Study ReportsInvestigator BrochuresOncology

Questions & Answers

Common questions about this position

Is this Medical Director position remote or home-based?

Yes, the position is home-based.

What is the salary or compensation for this role?

This information is not specified in the job description.

What are the key responsibilities of the Medical Director?

The Medical Director provides medical oversight for clinical trials as Medical Monitor, offers medical and scientific input to programs including protocol review and adverse event evaluation, interacts with clients and thought leaders on study design, and ensures activities comply with GCP.

What is the structure of the medical department team?

The medical department consists of a Chief Medical Officer, Medical Directors, Sr Medical Directors, Medical Writers, and Safety Associates, with the Medical Director functioning as a team member in a matrix reporting structure to project teams.

What makes a strong candidate for this Medical Director role?

A strong candidate has expertise in oncology or related therapeutic areas, experience in clinical trial medical monitoring, protocol development, GCP compliance, and the ability to network with investigators and thought leaders while providing 24/7 availability.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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